Fethi Trabelsi

Biography

 With a PhD and post-doctoral training in Physiology-Pharmacology at the Faculty of Pharmacy at the University of Montreal, Fethi has extensive experience in early clinical phase 1-2a drug development, including studies for PK/PD bioequivalence, Phase 1 SAD/MAD integrated design, Food effect, QTc, drug-drug interaction, Study in renal-impaired patients and Biosimilar development. He is an expert in Hybrid generic/505(b)(2) programs for EU and USA NDA submissions from initial Pre-IND meetings up until the NDA submission to the agency and also well versed in Biosimilar early clinical development

Research Interest

 experience in early clinical phase 1-2a drug development, including studies for PK/PD bioequivalence, Phase 1 SAD/MAD integrated design, Food effect, QTc, drug-drug interaction, Study in renal-impaired patients and Biosimilar development